How to keep up with changes on applicable technical standards (EU MDR)?

[zinochka]

Dear Community,

I work in the QM and regulatory area at a start-up. We are a small company with a limited budget and try to do as much as possible ourselves instead of paying for expensive consulting services or tools. I have a question about how to stay informed about changes in the regulatory field of the EU market at the lowest possible cost, i.e. no expensive tools or software? What I mean are e.g. changes to technical standards (harmonized standards) that you apply to meet the MDR GSPR for your products. Our Notified Body expects us to identify such changes immediately and take action. This is not always easy when you use many standards. At the moment we're doing an annual review to see what has changed, but I feel that an annual review isn't enough here because some changes happen between the two reviews and we didn't recognize them right away. Do you know where and how to be informed about planned changes and draft versions? That would be super helpful because you can brace yourself for a change to come. Or do you have some recommendations regarding the regulatory review and update process which can make our lives easier?

Your help is highly appreciated!
Thanks in advance!

 

[planB]

For harmonised standards, you might want to keep an eye on this related European Commission site.

They even offer an RSS feed you could use for monitoring. There is also an official newletter that typically contains updates to harmonised standards (when they happen).

While there is a (changing) list of standards to be harmonised, it is hard to predict when this is actually done; typically, the harmonisation process is a bumpy road full of delays.

Just be aware that as of today, the current and planned list of standards is probably not complete enough to allow for an assumption of conformity; you will need to include additional non-harmonised standards and maybe even have to address MDR requirements directly (such as the requirements on CMR/ED substances).

HTH,

 

[Cybel]

In addition, I use the "monitoring" function of this site: Search - evs.ee | en (where you can also find standards at reasonable cost).
Once you've selected the standards to be monitored, the service send you a notification via e-mail when a revision of a chosen standard is published or when the standard is withdrawn, corrected, amended or if a public enquiry is created about its draft.

 

[Ed Panek]

We use a service to notify us when things change. As their business relies on customer buying updates this works perfectly. They will notify you of the changes. ISO will not specify timing as thats left to regulatory bodies to decide.

We perform a review of the changes in a memo to file and if it is high risk to our device outline a plan for us to comply. If its not high risk We write a deliberation memo describing our analysis and decision logic.

 

[Sinus Tarsi]

@zinochka We were just cited for this a couple days ago! It was suggested that we do our "search" quarterly and not yearly. Every 3 months plan on taking a day or three to review the guidance updates for all of the areas you market to and then update accordingly...

 

[zinochka]

Thanks guys,

your advices are very helpful. Could you also share your experiences on how and where do you look for new standards that have recently been released in their first version? What is your approach in this case? And what about current draft versions, where do you look for them?

Thanks a lot in advance!

 

[DannyVerbiest]

In addition, I use the "monitoring" function of this site: (where you can also find standards at reasonable cost).
Once you've selected the standards to be monitored, the service send you a notification via e-mail when a revision of a chosen standard is published or when the standard is withdrawn, corrected, amended or if a public enquiry is created about its draft.

,

thanks for the tip! I am going to use this!